Physicochemical quality control of intravenous nitroglycerin injections marketed in Argentina (May-December 2022)

Abstract

The Directorate of Monitoring and Risk Management (INAME-ANMAT), through the Department of the National Control Laboratory
(LNC), designs annual work plans that include sampling drug products to control the quality of those under its competence. The criteria for executing a Sampling Plan for intravenous nitroglycerin injections were, on the one hand, the antecedent of a complaint to the Pharmacovigilance Service for lack of effectiveness in a product batch and, on the other hand, the relevance of their use as an anti-anginal agent in cardiovascular conditions, being these pathologies the ones that lead the cases of deaths in the Argentine Republic. This study aimed to carry out the quality control of the medicinal specialties authorized and marketed in our country between May and December 2022. The methodology used was “Nitroglycerin, Injection” (USP 44), which uses high-performance liquid chromatography (HPLC) with ultraviolet (UV) detection for the assay. The methodology was verified in terms of specificity against placebos and recovery, stability of the standard solution, and the system suitability, complying with its specifications. All the sampled lots complied with the identification and assay tests. The control, inspection, and surveillance of drug products carried out in this work contribute to the assessment of the safety, quality, and efficacy of health products, which is the mission of ANMAT.